Analytical Project Leader > Braine-l'Alleud > Joboolo BE :
Société : UCB Lieu : Braine-l'Alleud Wallonia Site source : Talent BE
In this position, you will contribute to the advancement of our portfolio of projects entering pre-clinical and clinical phases until commercial registration, launch and throughout the lifecycle of our marketed products.What you will do:
As a UCB AnalyticalProjectLeader you like to work in an environment where you can:
Have overall responsibility for the project management of the analytical activities and associated strategy in the field of Chemistry, Manufacturing and Controls (CMC) Development for defined therapeutic development projectsDefine and drive the analytical development strategy in full alignment with the other CMC and associated functions (R&D, Clinical and Commercial Supply Chains, Nonclinical and Clinical Development, CMC Quality Assurance, Regulatory Affairs, Commercial Manufacturing, Marketing)Plan, track, drive all project related analytical activities and expenditures.Be empowered to drive the decision-making process in a multidisciplinary matrix organization.Ensure fit for purpose and robust analytical deliverables with respect of the project timelines and costs for best patient solutions.The nature of the position is global and requires a strong understanding of all analytical development disciplinesAs a UCB AnalyticalProjectLeader you will contribute by the following activities:
To define the analytical development strategy and contribute to the high-level milestone plan (CMC Plan) in alignment with the overall UCB development strategyTo define the timelines, budget and resources and to coordinate all analytical activities to meet the overall project timelines and deliverablesTo act as the analytical single point of contact in the CMC development technical team, representing the different involved analytical departments (Analytical Sciences for Pharmaceuticals department, QCs, Contract Laboratory Organization (CLO) if necessary)To foster efficient collaboration with the other analytical functions in order to ensure high-quality fit-for-purpose analytical deliverables.To monitor progress against project plan and report progress updates to CMC development technical teamTo establish and track project budget for external activitiesTo update the CMC plan with respect to analytical activities on a regular agreed basis in line with updated global development plan and strategies.To prioritize the analytical activities effectively (in collaboration with Portfolio Team leaders) according to project timelines and resources constrains.To ensure effective communication with all other involved CMC and associated functions as well as with external partnersTo initiate risk assessments and development of risk mitigation strategies regarding analytical activitiesTo participate in improvement initiatives as required to ensure best in class project managementInterested? For this position you’ll need the following education, experience and skills:
Master’s degree in chemistry/sciencesStrong experience in pharmaceutical industry, including leadership positionsSolid understanding of the end-to-end CMC development (and associated disciplines) processStrong expertise in analytical development for synthetic molecules including method validation requirements, stability studies, forced degradation studies, excipient compatibility studies, impurity (organic, mutagenic, elemental) profile evaluation, specification settings with associated statistical expertise, etc.Detailed understanding of regulatory and GMP environments and requirements (ICH guidelines, Pharmacopoeias, etc.)Proven projectleadership skills, including project planning, monitoring, issue resolution, decision making and reportingOrganization & planning skillsStrong experience in budget management and cost control (resources evaluation, outsourcing cost definition, …)Proven team leadership, team building and networking skillsAbility to understand and balanced the prioritiesCustomer and result-oriented mindsetStrong sense of accountability and responsibilityCritical thinking capability (problem solving)Eagerness to continuously broaden and deepen your expertiseEffective and convincing communication English proficiency (oral, written), French is a plusAre you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you! UCB Braine-l'AlleudWallonia
